NCT04863937

Brief Summary

This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)). The hypothesis was that the DTCG group would display superior dynamic knee valgus FPPA compared to the standard knee sleeve and no device groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 21, 2021

Last Update Submit

April 27, 2021

Conditions

Keywords

Dynamic Knee Stability

Outcome Measures

Primary Outcomes (2)

  • Frontal Plane Knee Projection Angle

    Frontal plane tibio-femoral alignment at single leg triple hop completion

    Immediately after the intervention

  • Subject Confidence in Sports Safety and Performance Perceptions

    10-cm Visual Analog Confidence Scale for Sports Movement Capability and Safety Perceptions. Minimum value = 0. Maximum value = 100. Higher score equals greater confidence.

    Immediately after the intervention

Study Arms (1)

Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device

EXPERIMENTAL

Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device

Device: Distal Thigh Compression Garment, Knee Sleeve

Interventions

Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device

Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device

Eligibility Criteria

Age18 Years - 22 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale college athletes
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women
  • College athletes
  • ≥ 18 years

You may not qualify if:

  • Knee injury history
  • Any current lower extremity injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosair Charities College of Health and Natural Sciences

Louisville, Kentucky, 40203, United States

Location

Study Officials

  • John Nyland

    Spalding University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Devices were used in a randomized order. The outcomes assessor evaluated device differences based on device numerical assignment..
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 28, 2021

Study Start

March 26, 2018

Primary Completion

March 26, 2019

Study Completion

March 26, 2019

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Data collection has been completed. Information will be presented in published manuscript.

Locations